HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K043080 · Medtronic Vascular · JOX · Dec 3, 2004 · Hematology

Device Facts

• Record ID: K043080
• Device Name: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
• Applicant: Medtronic Vascular
• Product Code: JOX · Hematology
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Indications for Use

The controls are used to verify the performance of the appropriate cartridge on the HMS Plus instrument

Device Story

HDR Control set consists of single-use, non-sterile, in-vitro diagnostic plasma controls; used at point-of-care with HMS Plus instrument. Controls verify functionality of heparinized channels within HDR cartridges by measuring clotting time ratios between heparinized and unheparinized channels. HDR Control 1 verifies channels 1, 2, 5, and 6; HDR Control 2 verifies channels 3, 4, 5, and 6. Healthcare providers use these controls to ensure instrument and cartridge performance prior to clinical use, ensuring accurate heparin dose response monitoring for patients.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements; results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Lyophilized control material (sheep plasma, hexadimethrine bromide). Storage 2-10°C. Rehydration time 3 minutes. Reconstitution stability 1 hour at 15-25°C. Used with HMS Plus instrument and HDR cartridges. Pass/fail criteria based on clot time ratio range.

Indications for Use

Indicated for use as quality control materials to verify the performance of specific cartridges on the HMS Plus coagulation instrument.

Regulatory Classification

Identification

An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

Special Controls

*Classification.* Class II (special controls).

Predicate Devices

• HMS Controls (K894317)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K043080

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. HMS Coagulation System Cartridges and Controls, K042070
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of a bi-level, Heparin Dose Response (HDR) Control set.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, sample requirements, methodology, and performance.

Comparison of Predicate to Current Device

| Name | HMS Controls
K894317 | HR ACT Control
K894317 | HDR Controls |
| --- | --- | --- | --- |
| | | | |
| Indication for use | The controls are used to verify the performance of the appropriate cartridge on the HMS Plus instrument | Same | Same |
| Raw Material | Plasma and Heparin | Sheep ROB and Plasma | Sheep Plasma |
| Diluent | DI Water | DI Water | Hexadimethrine
Bromide Solution |
| Instrument | HMS and HMS Plus | Same | Same |
| Cartridge | HPT | HMS HR-ACT | HDR |
| Pass/Fail Criteria | Clot Time Cutoff + channel detect | Clot time range | Clot time ratio range |
| Storage Temp | 2-10°C | Same | Same |
| Rehydration Time | 3 minutes | 2 minutes | 3 minutes |
| Reconstitution stability | 2 hours at 2-25°C | 2 hours at 15-25°C | 1 hour at 15-25°C |
| Storage Type | Lyophilized | Same | Same |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

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b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

| (Reviewer's Signature) | 12-2-2004
(Date) |
| --- | --- |
| Comments | |

Revised: 8/1/03